Mark Kaufmann, M. Skelsey, Laura Ferris, Michael Walker, Andrew Rigby, Burkhard Jansen, Loren Clarke
Introduction: Non-invasive adjuncts to visual assessment of pigmented lesions may reduce biopsies of benign lesions without compromising melanoma detection. A non-invasive genomic melanoma rule-out assay analyzes RNA extracted from stratum corneum cells for PRAME and LINC00518, two genes commonly expressed in melanomas but less often in benign lesions. This study sought to characterize performance of this test in a large patient cohort tested in the real-world clinical setting. Methods: The test was applied to suspicious pigmented skin lesions at 63 U.S. dermatology and primary care practices. Test results (positive / negative) were compared to pathology diagnoses (melanoma / not melanoma) for lesions that were biopsied and to follow-up visual examination for those that were monitored. Results: Of 19,653 total lesions evaluated, 17,858 (90.87%) tested negative. Biopsy results and / or follow-up examinations were available for 5,096 lesions, with median and mean follow-up duration of 352 and 341 days, respectively. For melanoma, sensitivity was 95.8% and specificity was 69.4%. Positive predictive value (PPV) was 13.4%, and NPV was 99.7%. For melanoma and ‘borderline’ lesions combined, sensitivity was 94.2%, specificity was 71.2%, PPV was 20.8%, and NPV was 99.3%. Conclusion: The results suggest this noninvasive test can facilitate distinction of melanoma from its benign simulators, increasing the proportion of pigmented lesions that can be safely managed with surveillance rather than biopsy and/or excision.
{"title":"Real-World Performance of a Noninvasive Cutaneous Melanoma Rule-Out Test: A Multicenter U.S. Registry Study","authors":"Mark Kaufmann, M. Skelsey, Laura Ferris, Michael Walker, Andrew Rigby, Burkhard Jansen, Loren Clarke","doi":"10.25251/skin.8.3.8","DOIUrl":"https://doi.org/10.25251/skin.8.3.8","url":null,"abstract":"Introduction: Non-invasive adjuncts to visual assessment of pigmented lesions may reduce biopsies of benign lesions without compromising melanoma detection. A non-invasive genomic melanoma rule-out assay analyzes RNA extracted from stratum corneum cells for PRAME and LINC00518, two genes commonly expressed in melanomas but less often in benign lesions. This study sought to characterize performance of this test in a large patient cohort tested in the real-world clinical setting. \u0000Methods: The test was applied to suspicious pigmented skin lesions at 63 U.S. dermatology and primary care practices. Test results (positive / negative) were compared to pathology diagnoses (melanoma / not melanoma) for lesions that were biopsied and to follow-up visual examination for those that were monitored. \u0000Results: Of 19,653 total lesions evaluated, 17,858 (90.87%) tested negative. Biopsy results and / or follow-up examinations were available for 5,096 lesions, with median and mean follow-up duration of 352 and 341 days, respectively. For melanoma, sensitivity was 95.8% and specificity was 69.4%. Positive predictive value (PPV) was 13.4%, and NPV was 99.7%. For melanoma and ‘borderline’ lesions combined, sensitivity was 94.2%, specificity was 71.2%, PPV was 20.8%, and NPV was 99.3%. \u0000Conclusion: The results suggest this noninvasive test can facilitate distinction of melanoma from its benign simulators, increasing the proportion of pigmented lesions that can be safely managed with surveillance rather than biopsy and/or excision.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140982960","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Justin W Marson, Rebecca M. Chen, Michelle Schwartz, Daniel M. Siegel
Hydrocolloid dressings provide a maintenance-free method of post-procedural wound care. Commercially available hydrocolloid dressing, however, may not be accessible or affordable for all procedural patients. Here we report a case of a patient with a fibroepithelioma of pinkus treated with electrodessication and curettage with post-procedural wound care managed with an over-the-counter hydrocolloid “pimple” patch.
{"title":"Sealing the Deal: Embracing Hydrocolloid Dressings for Post Procedure Dermatologic Care","authors":"Justin W Marson, Rebecca M. Chen, Michelle Schwartz, Daniel M. Siegel","doi":"10.25251/skin.8.3.22","DOIUrl":"https://doi.org/10.25251/skin.8.3.22","url":null,"abstract":"Hydrocolloid dressings provide a maintenance-free method of post-procedural wound care. Commercially available hydrocolloid dressing, however, may not be accessible or affordable for all procedural patients. Here we report a case of a patient with a fibroepithelioma of pinkus treated with electrodessication and curettage with post-procedural wound care managed with an over-the-counter hydrocolloid “pimple” patch.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140984838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Uncle Charlie: Dennie-Morgan Lines","authors":"Domenica Del Pozo","doi":"10.25251/skin.8.3.25","DOIUrl":"https://doi.org/10.25251/skin.8.3.25","url":null,"abstract":"No Abstract.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140984806","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-18DOI: 10.25251/skin.8.supp.360
Joseph F. Merola, Milan J Anadkat, Neal Bhatia, Tina Bhutani, Laura Ferris, Arash Mostaghimi, .Jason Guercio, C. Thoma, Ming Tang, M. Lebwohl
Introduction & Objectives: Generalized pustular psoriasis (GPP) is a chronic inflammatory, potentially life-threatening skin disease, characterized by flares of sterile pustules. Spesolimab, an anti-interleukin-36 receptor monoclonal antibody, is approved to treat GPP flares in adults. Effisayil 2 (NCT04399837) evaluated the efficacy and safety of subcutaneous spesolimab in preventing GPP flares. Here, we report the effect of spesolimab versus placebo on Target Plaque Severity Score (TPSS) in patients with concomitant plaque psoriasis (PsO) in Effisayil 2. Materials & Methods: Eligible patients with a history of GPP were randomized (1:1:1:1) to high-dose spesolimab (loading dose 600 mg, maintenance dose 300 mg every 4 weeks), medium-dose spesolimab (loading: 600 mg, maintenance: 300 mg every 12 weeks), low-dose spesolimab (loading: 300 mg, maintenance: 150 mg every 12 weeks), or placebo for 48 weeks. One PsO lesion of ≥9 cm2 with TPSS total score ≥5 and induration sub-score ≥2 was selected by the investigator at baseline for each participant. Severity of erythema, scaling, and induration (plaque thickness) of the target lesion was assessed at baseline and subsequent visits on a 5-point scale (0, none to 4, very marked), with the summation of the 3 subscores representing the TPSS total score (0-12). Results: TPSS was measured in the 33/123 (27%) patients with PsO in the trial (9 placebo, 10 low-dose, 7 medium-dose, 7 high-dose). Mean TPSS total score was 4.2 in placebo and 4.6 in spesolimab-treated patients at baseline. By Week 4, mean TPSS remained similar in both groups (placebo, 4.3; spesolimab, 4.6). By Week 16, mean TPSS in the placebo group increased to 4.4 and decreased to 3.6 in spesolimab-treated patients. Mean TPSS total scores at Week 48 for both groups were below baseline (placebo, 3.3; spesolimab, 3.8). The number of patients with TPSS data declined in both groups over time due to GPP flare and/or early discontinuation. Conclusion: Low baseline TPSS scores observed in this subpopulation of 33 GPP patients with concomitant PsO suggest that concomitant PsO plaque characteristics in GPP are generally mild to moderate. TPSS scores remained low and consistent throughout the trial in both dosing groups and decreases in TPSS score by Week 16 (spesolimab-treated) and Week 48 (both groups) compared to baseline were observed.
{"title":"Spesolimab Use for Generalized Pustular Psoriasis Flare Prevention in Patients with Concomitant Plaque Psoriasis: Results from the Effisayil 2 Trial","authors":"Joseph F. Merola, Milan J Anadkat, Neal Bhatia, Tina Bhutani, Laura Ferris, Arash Mostaghimi, .Jason Guercio, C. Thoma, Ming Tang, M. Lebwohl","doi":"10.25251/skin.8.supp.360","DOIUrl":"https://doi.org/10.25251/skin.8.supp.360","url":null,"abstract":"Introduction & Objectives: Generalized pustular psoriasis (GPP) is a chronic inflammatory, potentially life-threatening skin disease, characterized by flares of sterile pustules. Spesolimab, an anti-interleukin-36 receptor monoclonal antibody, is approved to treat GPP flares in adults. Effisayil 2 (NCT04399837) evaluated the efficacy and safety of subcutaneous spesolimab in preventing GPP flares. Here, we report the effect of spesolimab versus placebo on Target Plaque Severity Score (TPSS) in patients with concomitant plaque psoriasis (PsO) in Effisayil 2. \u0000Materials & Methods: Eligible patients with a history of GPP were randomized (1:1:1:1) to high-dose spesolimab (loading dose 600 mg, maintenance dose 300 mg every 4 weeks), medium-dose spesolimab (loading: 600 mg, maintenance: 300 mg every 12 weeks), low-dose spesolimab (loading: 300 mg, maintenance: 150 mg every 12 weeks), or placebo for 48 weeks. One PsO lesion of ≥9 cm2 with TPSS total score ≥5 and induration sub-score ≥2 was selected by the investigator at baseline for each participant. Severity of erythema, scaling, and induration (plaque thickness) of the target lesion was assessed at baseline and subsequent visits on a 5-point scale (0, none to 4, very marked), with the summation of the 3 subscores representing the TPSS total score (0-12). \u0000Results: TPSS was measured in the 33/123 (27%) patients with PsO in the trial (9 placebo, 10 low-dose, 7 medium-dose, 7 high-dose). Mean TPSS total score was 4.2 in placebo and 4.6 in spesolimab-treated patients at baseline. By Week 4, mean TPSS remained similar in both groups (placebo, 4.3; spesolimab, 4.6). By Week 16, mean TPSS in the placebo group increased to 4.4 and decreased to 3.6 in spesolimab-treated patients. Mean TPSS total scores at Week 48 for both groups were below baseline (placebo, 3.3; spesolimab, 3.8). The number of patients with TPSS data declined in both groups over time due to GPP flare and/or early discontinuation. \u0000Conclusion: Low baseline TPSS scores observed in this subpopulation of 33 GPP patients with concomitant PsO suggest that concomitant PsO plaque characteristics in GPP are generally mild to moderate. TPSS scores remained low and consistent throughout the trial in both dosing groups and decreases in TPSS score by Week 16 (spesolimab-treated) and Week 48 (both groups) compared to baseline were observed.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140232754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Laser therapy has been popular and widely used for tattoo removal. Basic principles for utilizing lasers in tattoo removal for different types and colors of tattoos are required to minimize and avoid unwanted side effects. Appropriate parameters of lasers are not the only keys to successful laser removal treatment. In this review, common pitfalls in removing tattoos with lasers are discussed. Several factors should be taken into consideration and realistic goals should be discussed at the first encounter with patients. Non-ablative lasers may apply to a simple tattoo without any cutaneous reaction while ablative lasers are better for traumatic tattoos. Laser is not always the best option for tattoo removal in some circumstances and other measures can be considered for the best interest of patients and outcome.
{"title":"Pitfalls in Laser-Based Device Tattoo Removal: A Literature Review","authors":"Nattanicha Chaisrimaneepan","doi":"10.25251/skin.8.2.4","DOIUrl":"https://doi.org/10.25251/skin.8.2.4","url":null,"abstract":"Laser therapy has been popular and widely used for tattoo removal. Basic principles for utilizing lasers in tattoo removal for different types and colors of tattoos are required to minimize and avoid unwanted side effects. Appropriate parameters of lasers are not the only keys to successful laser removal treatment. In this review, common pitfalls in removing tattoos with lasers are discussed. Several factors should be taken into consideration and realistic goals should be discussed at the first encounter with patients. Non-ablative lasers may apply to a simple tattoo without any cutaneous reaction while ablative lasers are better for traumatic tattoos. Laser is not always the best option for tattoo removal in some circumstances and other measures can be considered for the best interest of patients and outcome.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140233004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-18DOI: 10.25251/skin.8.supp.384
M. Skelsey, Brent Loftis, Mark Kaufmann, Daniel Siegel, Neal Bhatia, Michael Walker, Andrew Rigby, John Whitaker, Steven Stone, Mary Mocia, Kaleigh O'Brien, Loren Clark, Burkhard Jansen
{"title":"Non-invasive Gene Expression Analysis Rules Out Melanoma with High Negative Predictive Value Regardless of Skin Phototype","authors":"M. Skelsey, Brent Loftis, Mark Kaufmann, Daniel Siegel, Neal Bhatia, Michael Walker, Andrew Rigby, John Whitaker, Steven Stone, Mary Mocia, Kaleigh O'Brien, Loren Clark, Burkhard Jansen","doi":"10.25251/skin.8.supp.384","DOIUrl":"https://doi.org/10.25251/skin.8.supp.384","url":null,"abstract":"","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140233893","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Verrucous cyst is an uncommon manifestation of human papilloma virus infection. Diagnosis is histopathological and characterized by verrucous changes in an epidermal cyst. This is a report of verrucous cyst in a seven (7) year old girl who had an asymptomatic nodule on her hand. Case Report: 7-year old girl who had a nodule on the palmar surface of her left hand. A clinical diagnosis of foreign body granuloma was made. Biopsy and histopathology was consistent with a verrucous cyst Conclusion: The need for histopathological evaluation of skin growths is highlighted by this case report.
{"title":"Verrucous Cyst in a 7-year-old Girl","authors":"E. Anaba, M. W. Rasheed","doi":"10.25251/skin.8.2.10","DOIUrl":"https://doi.org/10.25251/skin.8.2.10","url":null,"abstract":"Background: Verrucous cyst is an uncommon manifestation of human papilloma virus infection. Diagnosis is histopathological and characterized by verrucous changes in an epidermal cyst. This is a report of verrucous cyst in a seven (7) year old girl who had an asymptomatic nodule on her hand. \u0000Case Report: 7-year old girl who had a nodule on the palmar surface of her left hand. A clinical diagnosis of foreign body granuloma was made. Biopsy and histopathology was consistent with a verrucous cyst \u0000Conclusion: The need for histopathological evaluation of skin growths is highlighted by this case report. \u0000 ","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140231539","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-18DOI: 10.25251/skin.8.supp.390
L. Eichenfield, Adelaide A. Hebert, Julie C Harper, Hilary Baldwin, Neal Bhatia, L. Stein Gold, L. Kircik, Emmy Graber, Emil Tanghetti, Andrew F. Alexis, James Q Del Rosso
Background: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the first fixed-dose triple-combination formulation approved for acne vulgaris and is indicated for use in patients aged 12 years and older. As topical acne treatment in pediatric patients may be complicated by tolerability issues and/or a perceived lack of efficacy, the objective of this post hoc analysis was to investigate the efficacy and safety of CAB in children and adolescents. Methods: Data were pooled from two phase 3 double-blind, randomized, 12-week studies (NCT04214639; NCT04214652). Eligible participants ≥9 years of age with moderate-to-severe acne were randomized (2:1) to once-daily CAB or vehicle gel. This analysis evaluated adolescents aged 12-17 years (CAB: n=123; vehicle: n=50). Endpoints included ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin (treatment success), least-squares mean percent change from baseline in inflammatory/noninflammatory lesions, and treatment-emergent adverse events (TEAEs). Descriptive efficacy and safety data for five children aged 10-11 years enrolled in the study are also summarized (CAB: n=3; vehicle: n=2). Results: At week 12, 51.5% of CAB–treated participants aged ≥12 years achieved treatment success vs 24.9% with vehicle gel (P<0.01). CAB treatment resulted in significant reductions of >70% in inflammatory and noninflammatory lesion counts in adolescents (78.3% and 73.7%, respectively) vs vehicle (50.5% and 42.9%; P<0.001, both). Most TEAEs were of mild-to-moderate severity, and the most common (>3% in any treatment) treatment-related TEAE was application site pain. Less than 2.5% of participants withdrew due to AEs. For the 5 children aged <12 years, all 3 treated with CAB achieved treatment success, with reductions in inflammatory/noninflammatory lesions ranging from 76%-100%; neither vehicle-treated participant achieved treatment success. Only one CAB–treated younger participant experienced TEAEs (application site pain/dryness, and erythema [all mild/moderate]) and none discontinued the study. Conclusions: In two pooled phase 3 studies, once-daily CAB gel—the first approved fixed-dose, triple-combination topical formulation for acne vulgaris—was well tolerated and efficacious in pediatric participants with moderate-to-severe acne, with over half achieving treatment success at week 12. Funding: Ortho Dermatologics
{"title":"Efficacy and Safety of Fixed-Dose Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne Vulgaris in Children and Adolescents","authors":"L. Eichenfield, Adelaide A. Hebert, Julie C Harper, Hilary Baldwin, Neal Bhatia, L. Stein Gold, L. Kircik, Emmy Graber, Emil Tanghetti, Andrew F. Alexis, James Q Del Rosso","doi":"10.25251/skin.8.supp.390","DOIUrl":"https://doi.org/10.25251/skin.8.supp.390","url":null,"abstract":"Background: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the first fixed-dose triple-combination formulation approved for acne vulgaris and is indicated for use in patients aged 12 years and older. As topical acne treatment in pediatric patients may be complicated by tolerability issues and/or a perceived lack of efficacy, the objective of this post hoc analysis was to investigate the efficacy and safety of CAB in children and adolescents. \u0000Methods: Data were pooled from two phase 3 double-blind, randomized, 12-week studies (NCT04214639; NCT04214652). Eligible participants ≥9 years of age with moderate-to-severe acne were randomized (2:1) to once-daily CAB or vehicle gel. This analysis evaluated adolescents aged 12-17 years (CAB: n=123; vehicle: n=50). Endpoints included ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin (treatment success), least-squares mean percent change from baseline in inflammatory/noninflammatory lesions, and treatment-emergent adverse events (TEAEs). Descriptive efficacy and safety data for five children aged 10-11 years enrolled in the study are also summarized (CAB: n=3; vehicle: n=2). \u0000Results: At week 12, 51.5% of CAB–treated participants aged ≥12 years achieved treatment success vs 24.9% with vehicle gel (P<0.01). CAB treatment resulted in significant reductions of >70% in inflammatory and noninflammatory lesion counts in adolescents (78.3% and 73.7%, respectively) vs vehicle (50.5% and 42.9%; P<0.001, both). Most TEAEs were of mild-to-moderate severity, and the most common (>3% in any treatment) treatment-related TEAE was application site pain. Less than 2.5% of participants withdrew due to AEs. For the 5 children aged <12 years, all 3 treated with CAB achieved treatment success, with reductions in inflammatory/noninflammatory lesions ranging from 76%-100%; neither vehicle-treated participant achieved treatment success. Only one CAB–treated younger participant experienced TEAEs (application site pain/dryness, and erythema [all mild/moderate]) and none discontinued the study. \u0000Conclusions: In two pooled phase 3 studies, once-daily CAB gel—the first approved fixed-dose, triple-combination topical formulation for acne vulgaris—was well tolerated and efficacious in pediatric participants with moderate-to-severe acne, with over half achieving treatment success at week 12. \u0000Funding: Ortho Dermatologics","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140234593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-18DOI: 10.25251/skin.8.supp.379
Amy S. Paller, L. Eichenfield, Jonathan I. Silverberg, M. Cork, Christine Bangert, Alan Irvine, S. Weidinger, Sebastien Barbarot, Haiyun Fan, J. Alderfer, H. Koppensteiner, Kanti Chittuluru
Introduction: Abrocitinib, an oral, once-daily, Janus kinase 1–selective inhibitor, was efficacious and well tolerated in adolescent patients with moderate-to-severe atopic dermatitis (AD) exposed for approximately 1 year of treatment. Here, we describe the updated long-term integrated safety profile of abrocitinib in adolescent patients in the JADE clinical program.Methods: A total of 635 adolescent patients (12 to <18 years; exposure: 1011.4 patient-years [PY]) were pooled for safety analysis from the phase 3 JADE clinical trials MONO-1 (NCT03349060), MONO-2 (NCT03575871), TEEN (NCT03796676), and REGIMEN (NCT03627767) and subsequently enrolled in the ongoing phase 3 extension trial JADE EXTEND (NCT03422822; data cutoff: September 25, 2021). Incidence rates (IRs; number of unique patients with events/100 PY) of severe adverse events (SAEs) and AEs of special interest were assessed.Results: Of the total 635 adolescents, 490 received the same abrocitinib dose throughout exposure (730.6 PY); 289 received abrocitinib 200 mg (424.5 PY) and 201 received abrocitinib 100 mg (306.1 PY). Duration of exposure was ≥96 weeks in 38% and 37%, and ≥144 weeks in 8% and 4% of patients who received abrocitinib 200 mg or 100 mg, respectively. In the 200-mg and 100-mg arms, AEs occurred in 243 (84%) and 153 (76%) patients; 8% (IR [95% CI], 5.87 [3.76-8.74]) and 9% (5.87 [3.48-9.27]) experienced SAEs, and 10% (6.96 [4.69-9.93]) and 8% (5.13 [2.93-8.33]) discontinued the study due to AEs, respectively. IRs of AEs of special interest were 1.84 (95% CI, 0.79-3.62) and 1.28 (0.35-3.27) for serious infection, 2.11 (0.97-4.01) and 1.62 (0.53-3.77) for all herpes zoster (HZ) infections, and 0.69 (0.14-2.03) and 0.32 (0.01-1.77) for opportunistic HZ infections in the 200-mg and 100-mg arms, respectively. One patient (aged 16 years) in the 200-mg arm had a nonfatal venous thromboembolism event (pulmonary embolism; IR, 0.23 [95% CI, 0.01-1.28]); patient had a family history of pulmonary embolism. There were no events of nonmelanoma skin cancer or other malignancies, tuberculosis, or other opportunistic infections (excluding HZ), major adverse cardiovascular events, or deaths.Conclusions: In this integrated safety analysis using the September 2021 data cut from the ongoing JADE EXTEND trial, abrocitinib had an acceptable long-term safety profile in adolescents with moderate-to-severe AD.
{"title":"Integrated Safety Analysis of Abrocitinib in 635 Adolescent Patients With Moderate-To-Severe Atopic Dermatitis With Over 1000 Patient-Years of Exposure","authors":"Amy S. Paller, L. Eichenfield, Jonathan I. Silverberg, M. Cork, Christine Bangert, Alan Irvine, S. Weidinger, Sebastien Barbarot, Haiyun Fan, J. Alderfer, H. Koppensteiner, Kanti Chittuluru","doi":"10.25251/skin.8.supp.379","DOIUrl":"https://doi.org/10.25251/skin.8.supp.379","url":null,"abstract":"Introduction: Abrocitinib, an oral, once-daily, Janus kinase 1–selective inhibitor, was efficacious and well tolerated in adolescent patients with moderate-to-severe atopic dermatitis (AD) exposed for approximately 1 year of treatment. Here, we describe the updated long-term integrated safety profile of abrocitinib in adolescent patients in the JADE clinical program.Methods: A total of 635 adolescent patients (12 to <18 years; exposure: 1011.4 patient-years [PY]) were pooled for safety analysis from the phase 3 JADE clinical trials MONO-1 (NCT03349060), MONO-2 (NCT03575871), TEEN (NCT03796676), and REGIMEN (NCT03627767) and subsequently enrolled in the ongoing phase 3 extension trial JADE EXTEND (NCT03422822; data cutoff: September 25, 2021). Incidence rates (IRs; number of unique patients with events/100 PY) of severe adverse events (SAEs) and AEs of special interest were assessed.Results: Of the total 635 adolescents, 490 received the same abrocitinib dose throughout exposure (730.6 PY); 289 received abrocitinib 200 mg (424.5 PY) and 201 received abrocitinib 100 mg (306.1 PY). Duration of exposure was ≥96 weeks in 38% and 37%, and ≥144 weeks in 8% and 4% of patients who received abrocitinib 200 mg or 100 mg, respectively. In the 200-mg and 100-mg arms, AEs occurred in 243 (84%) and 153 (76%) patients; 8% (IR [95% CI], 5.87 [3.76-8.74]) and 9% (5.87 [3.48-9.27]) experienced SAEs, and 10% (6.96 [4.69-9.93]) and 8% (5.13 [2.93-8.33]) discontinued the study due to AEs, respectively. IRs of AEs of special interest were 1.84 (95% CI, 0.79-3.62) and 1.28 (0.35-3.27) for serious infection, 2.11 (0.97-4.01) and 1.62 (0.53-3.77) for all herpes zoster (HZ) infections, and 0.69 (0.14-2.03) and 0.32 (0.01-1.77) for opportunistic HZ infections in the 200-mg and 100-mg arms, respectively. One patient (aged 16 years) in the 200-mg arm had a nonfatal venous thromboembolism event (pulmonary embolism; IR, 0.23 [95% CI, 0.01-1.28]); patient had a family history of pulmonary embolism. There were no events of nonmelanoma skin cancer or other malignancies, tuberculosis, or other opportunistic infections (excluding HZ), major adverse cardiovascular events, or deaths.Conclusions: In this integrated safety analysis using the September 2021 data cut from the ongoing JADE EXTEND trial, abrocitinib had an acceptable long-term safety profile in adolescents with moderate-to-severe AD.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140234420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Coinciding Erythema Nodosum and Sweet Syndrome","authors":"Philip Cohen","doi":"10.25251/skin.8.2.23","DOIUrl":"https://doi.org/10.25251/skin.8.2.23","url":null,"abstract":"","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140231895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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